Varenicline N-methyl Impurity (CAS 328055-92-1) | conocido también como 8-Methyl-7 | 8 | 9 | 10-tetrahydro-6H-6 | 10-methanoazepino[4 | 5-g]quinoxaline Dihydrochloride | es una impureza estructuralmente relacionada con el principio activo que puede formarse durante etapas de síntesis | en particular en reacciones de metilación de la amina o en procesos de trabajo con sales. Desde el punto de vista analítico y regulatorio su presencia impacta la pureza del lote y requiere perfilado mediante HPLC-MS | NMR y ensayos de rutina para control de impurezas según ICH. Su trazabilidad | especificación de límites y estándar de referencia son críticos para la validación de métodos y la garantía de calidad del API.
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